FDA.reportPublic FDA data

N.A.

Primary DI
04049368172512
Brand
N.A.
Company
Geuder Aktiengesellschaft
Model
40008
Catalog number
40008
Device description
N.A.
Published
2021-02-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HNRForceps, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNRForceps, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049368172512PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049368172512040493681725124049368172512

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical instrument handle, manualA hand-held manual device designed to hold and operate a compatible ophthalmic surgical instrument tip (typically scissors, forceps). It is typically in the form of a conventional handle with a connector that secures the inserted tip, and has a manually-operated internal actuating piston that operates the inserted tip (e.g., opens and closes blades). It is typically used for surgery in the anterior or the posterior segment to cut, grasp, and manipulate eye tissue; it is not a handle for a corneal trephine. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
316267202
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049368016328N.A.38240382402021-02-23
04049368145219N.A.38210382102021-02-23
04049368145226N.A.38215382152021-02-23
04049368172505N.A.40006400062021-02-23
04049368014201N.A.33960339602021-02-23
04049368015420N.A.38634386342021-02-23
04049368114154N.A.31306313062021-02-23
04049368127895N.A.32935329352021-02-23
04049368127925N.A.32936329362021-02-23
04049368127932N.A.32937329372021-02-23
04049368127994N.A.32944329442021-02-23
04049368133810N.A.33831338312021-02-23
04049368140818N.A.36282362822021-02-23
04049368141181N.A.36312363122021-02-23
04049368141631N.A.36364363642021-02-23
04049368141648N.A.36366363662021-02-23
04049368141655N.A.36368363682021-02-23
04049368169680N.A.32947329472021-02-23
04049368171423N.A.38606386062021-02-23
04049368172628N.A.42341423412021-02-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00192896123779Waever Chalazion ForcepsSONTEC INSTRUMENTS, INC.HNR2026-09-18
00192896123786Prince Trachoma Eye ForcepsSONTEC INSTRUMENTS, INC.HNR2026-09-18
14546951639997MANI MICRO FORCEPSMANI, INC.HNR2026-09-18
14546951640009MANI MICRO FORCEPSMANI, INC.HNR2026-09-18
14546951640016MANI MICRO FORCEPSMANI, INC.HNR2026-09-18
14546951640023MANI MICRO FORCEPSMANI, INC.HNR2026-09-18
14546951640030MANI MICRO FORCEPSMANI, INC.HNR2026-09-18
14546951640047MANI MICRO FORCEPSMANI, INC.HNR2026-09-18
14546951640054MANI MICRO FORCEPSMANI, INC.HNR2026-09-18
14546951640061MANI MICRO FORCEPSMANI, INC.HNR2026-09-18
14546951640078MANI MICRO FORCEPSMANI, INC.HNR2026-09-18
14546951640085MANI MICRO FORCEPSMANI, INC.HNR2026-09-18
14546951640092MANI MICRO FORCEPSMANI, INC.HNR2026-09-18
14546951640108MANI MICRO FORCEPSMANI, INC.HNR2026-09-18
14546951640115MANI MICRO FORCEPSMANI, INC.HNR2026-09-18
14546951640122MANI MICRO FORCEPSMANI, INC.HNR2026-09-18
04059453116635Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHNR2026-08-25
00190776426576MillenniumAvalign Technologies, Inc.HNR2026-08-19
00190776426774MillenniumAvalign Technologies, Inc.HNR2026-08-19
00198506093975ELMED INCORPORATEDELMED INCORPORATEDHNR2026-08-18
G346EA41HSS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNR2026-08-14
00190776411480MillenniumAvalign Technologies, Inc.HNR2026-08-07
00860013297954Ziplyft Upper Eyelid Lift KitOsheru, L.L.C.HNR2026-08-07
B382SD9028531640Surgical DirectSurgical Direct, Inc.HNR2026-08-07
G22312552000Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNR2026-08-03
00840319759202Hayden MedicalHayden Medical, Inc.HNR2026-07-30
G2231114060Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNR2026-07-27
G2231119000Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNR2026-07-27
G223111901T0Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNR2026-07-27
G22312408910Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNR2026-07-27